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CMS’s final decision is that monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
Despite criticism from Aduhelm manufacturer Biogen and Alzheimer’s disease (AD) advocacy groups, the Centers for Medicare and Medicaid Services (CMS) confirmed that Medicare will only cover Aduhelm for patients in specific clinical trials.
In its final Medicare national coverage determination (NCD), CMS said FDA-approved monoclonal antibodies to treat Alzheimer’s disease may only be covered in a randomized controlled trial conducted under an investigational new drug application.
“Monoclonal antibodies directed against amyloid that are approved by FDA for the treatment of AD based upon evidence of efficacy from a direct measure of clinical benefit may be covered in CMS-approved prospective comparative studies,” CMS said in a news release.
Biogen and AD patient advocacy groups criticized CMS’s final NCD.
“This unprecedented CMS decision effectively denies all Medicare beneficiaries access to Aduhelm (aducanumab-avwa), the first and only FDA-approved therapy in a new class of Alzheimer’s drugs,” Biogen said in a statement.
The determination may also “limit coverage for any future approved treatment in the class,” Biogen said. “These coverage restrictions, including the distinction between accelerated approval and traditional approval, have never been applied to FDA-approved medicines for other disease areas.”
When additional data from this new class of treatments become available, Biogen urges CMS to reconsider its decision for all FDA-approved amyloid-beta targeting therapies.
Biogen is “carefully considering its options and will provide updates as the company further evaluates the business impact of this decision.”
Meanwhile, UsAgainstAlzheimer’s Chair and Co-founder George Vradenburg issued a more strongly worded statement.
“CMS has made discrimination against Alzheimer’s patients an official policy. In an unprecedented move, the agency formalized its plan to deny Medicare coverage to Alzheimer’s patients to FDA-approved Alzheimer’s treatments, something it has never done with any other patient group,” Vradenburg said. “It’s unconscionable and reprehensible that CMS would force Alzheimer’s patients to play by a different set of rules than patients with other diseases like cancer and HIV.”
CMS attempted to paint the final coverage determination as an improvement over the draft it released in January, Vradenburg noted. “The truth is there is little change and a lot more uncertainty — uncertainty for Alzheimer’s patients who need treatment, uncertainty for industry and innovation, and uncertainty for other disease groups using the FDA’s Accelerated Approval Process to access innovative medicines more quickly.”
“Medicare has an obligation to provide patient access to Alzheimer’s treatments the same way it does every other FDA-approved drug. Our work won’t stop until they do,” Vradenburg added.
Meanwhile, CMS said its final decision allows for flexibility in a less rigorous study design for anti-amyloid mAbs that have been approved by FDA through the traditional approval process for the treatment of AD, “based upon evidence of efficacy from a direct measure of clinical benefit.”
“For anti-amyloid mAbs that have demonstrated a meaningful clinical benefit through the FDA traditional approval process, that anti-amyloid mAb is eligible to be used on label, for FDA-approved indications, in clinical studies or other prospective comparative studies to answer the CED questions specified in the NCD,” CMS said.
While the degree of rigor in the coverage with evidence development (CED) study design for a particular anti-amyloid mAb will be determined in large part by the strength of evidence in the initial, successful trial(s) that lead to FDA approval of that particular drug, one example is of a study that generated data through routine clinical practice or a registry, CMS noted.
“Registry data may then be used to assess whether outcomes seen in carefully controlled clinical trials are reproduced in real-world use and in a broader range of patient groups,” CMS added.